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Vaccines, Blood & Biologics

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Vaccines

Review Memo, January 11, 2010 - MenHibrix

MEMORANDUM     
DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research
_____________________________________________________________________________

Date:   January 11, 2010

From:  Anissa M. Cheung

Through:  Jerry Weir

Subject:  Review of the -----------------(b)(4)------------------- ------- for the detection of
Influenza antibodies after co-administration with MENHIBRIX

Sponsor:  GlaxoSmithKline Biologicals

Title:   MENHIBRIX (Meningococcal Groups C and Y and Hemophilus b Tetanus
Toxoid Conjugate Vaccine)

To:   License Application File 125363/0
Joseph Temenak

GlaxoSmithKline (GSK) Biologicals’ candidate vaccine, MENHIBRIX (originally designated as Hib-MenCY-TT under IND (b)(4)-, is composed of three active ingredients: the purified capsular polysaccharides of Hemophilus influenza type b, Neisseria meningitides group C and Neisseria meningitides group Y, each conjugated to tetanus toxoid. The proposed indication for MENHIBRIX is 6 weeks through 15 months of age for active immunization in infants and toddlers for prevention of invasive diseases caused by Hemophilus influenza type b and Neisseria meningitides serogroups C and Y.

During the June 8, 2005 pre-phase 3 meeting, CBER agreed to GSK’s proposal to permit co-administration of influenza vaccine in the Phase 3 study of this candidate vaccine. An exploratory evaluation of the difference in immune response to the Influenza vaccine for cohorts between the MENHIBRIX group and Hib group (licensed comparator) was studied in clinical protocol Hib-MenCY-TT-010. I am responsible for the review their --------(b)(4)------------------------- as well as the validation report. The  ---------(b)(4)-------------------------- is used for the detection of influenza antibodies in subjects who received 2 doses of influenza vaccines within the same influenza season of which one dose was concomitant with the study vaccine or the licensed comparator.

--------------------------------(b)(4)-----------------------------

----------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)------------------------------------------------------------------------------------------------------------------------------------------------------------------- -----------------------------------------------------------------------------------------------------------------------------------------(b)(4)------------------------------------------------------------------------------:

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  • ---------------------------------(b)(4)--------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.

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  • -------------------------------------------------------------------------------------------------------------------------------------(b)(4)-------------------------------------------------------------------------------------------------------.
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------------------------------------(b)(4)------------------------------------------------------

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Reviewer’s Conclusion:

-----------------(b)(4)-------------------- is the standard assay used to detect protective immune response elicited after influenza virus vaccination and it measures (b)(4) in the clinical human sera. This is the same assay used in the clinical studies of Fluarix, a U.S. licensed inactivated influenza vaccine. I agree that their ---------(b)(4)--------------------------------- is qualified to be used to compare the immune response to the Influenza vaccine for cohorts between the MENHIBRIX group and Hib group studied in clinical protocol Hib-MenCY-TT-010; however, the assay could be improved by incorporating a test serum control, which includes the test serum sample and the ----(b)(4)-------------- to detect the non-specific agglutinins that may present in the test serum sample. Ideally, in their validation study, additional parameters like specificity, linearity, and range should be included in their qualification plan.